Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "FCC to Hire Health Director, Improve mHealth Collaborations with FDA."
Following is an excerpt:
FCC Commissioner Julius Genanchowski said the agency plans to hire a health care director and work with industry and federal partners to make mobile technology a routine medical practice within five years. ?...
"Over the last few years there hasn't been anyone for [FDA device center policy advisor] Bakul Patel or anyone else at the FDA to just pick up the phone and reach out to," said Bradley Merrill Thompson, general counsel for the mHealth Regulatory Coalition. "I think the moves to more fully staff at FCC create opportunities for dialogue." ?...
Thompson said the increased collaboration between the agencies could lead to the development of FDA policies that are more supportive of innovation in the mobile health industry.
The FCC is a different type of regulator because its focus is on promoting the use of broadband and technologies whereas FDA is usually in the position of having to say "no" to industry, Thompson said. Meetings between the two agencies could be more positive than those between FDA and industry, he said, adding that FCC could get FDA to regulate with a "lighter touch."
He said that could be important as the conversation moves beyond what mobile health devices FDA should regulate to how FDA should regulate them.
"In mHealth we're still struggling with what gets regulated," Thompson tells FDA Week. "Very soon we're going to move from what gets regulated to how it gets regulated. FDA is going to have to work out what the regulatory policies look like. Inviting FCC into the process allows FDA to come up with a more practical way to regulate."
